Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition. |
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Authors: | Faiez Zannad Wendy Gattis Stough Bertram Pitt John G F Cleland Kirkwood F Adams Nancy L Geller Christian Torp-Pedersen Bridget-Anne Kirwan Ferenc Follath |
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Institution: | Hypertension and Preventive Cardiology Division, Department of Cardiovascular Disease, Centre d'Investigations Cliniques INSERM-CHU, INSERM U684, H?pital Jeanne d' Arc, 54200 Dommartin-les-Toul, Nancy, France. f.zannad@chu-nancy.fr |
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Abstract: | Specific criteria have been established to define the occurrence of myocardial infarction (MI) and stroke in cardiovascular clinical trials, but there is not a consistent definition for heart failure. Heart failure events appear to occur at a rate that is similar to stroke and MI in trials of hypertension, hyperlipidaemia, diabetes, and coronary heart disease, yet a consistent approach to defining heart failure events has not yet been realized. The wide range of definitions used in clinical trials makes it difficult to interpret new data in the context of existing literature. This inconsistency has led to challenges in determining the incidence of heart failure in cardiovascular studies and the effects of interventions on these endpoints. This paper examines issues related to defining heart failure events in cardiovascular clinical trials and presents a definition to formally address this issue. |
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Keywords: | Cardiovascular disease Heart failure Clinical trials Hypertension Hypercholesterolaemia |
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